The present invention relates to surgical retractors and stabilization devices for engaging a predetermined area of the body during a surgical procedure, more particularly to surgical retractors and stabilizing devices used in connection with coronary artery bypass grafting surgical procedures, and more specifically to surgical retractors and stabilizing devices particularly configured for use with each other for such surgical procedures.
The present application is related to U.S. Ser. No. 60/117,333 filed on Jan. 24, 1999 and U.S. Ser. No. 09/345,859 filed on Jul. 1, 1999 the priority thereof is claimed hereby and the disclosures thereof are incorporated herein by reference.
Diseases of the cardiovascular system affect millions of people each year and are a cause of death for large numbers of people in the United States and throughout the world. A particularly prevalent form of cardiovascular disease involves a reduction in the blood supply to the heart caused by atherosclerosis (coronary artery disease) or other conditions that create a restriction in blood flow at a critical point in the cardiovascular system leading to the heart.
One technique for treating such a blockage or restriction is a surgical procedure known as a coronary artery bypass graft procedure, which is more commonly known as xe2x80x9ca heart bypassxe2x80x9d operation. The surgical correction of occluded or stenosed coronary arteries by means of bypass grafting are probably still the most common procedures performed today, especially when multiple grafts are needed.
In the coronary artery bypass graft procedure, the surgeon may remove a portion of a vein from another part of the body for grafting or detaches one end of a local artery and connects that end past the obstruction while leaving the other end attached to the existing arterial supply. When using a vein from another part of the body, the surgeon installs this portion at points that bypass the obstruction. In both cases, the objective is to restore normal blood flow to the heart.
In addition, when using this technique, the surgeon makes a long incision down the middle of the chest, saws through the sternum, spreads the two halves of the sternum apart. In the past, the surgeon then performed several procedures necessary to connect the surgical patient to a cardiopulmonary bypass machine to continue the circulation of oxygenated blood to the rest of the body while the heart is stopped and the graft is being sewn in place. Although such a procedure is one common technique, the procedure is lengthy, traumatic and can damage the heart, the central nervous system and the blood supply of the patient.
Interventional techniques, such as percutaneous transluminal angioplasty (PTCA) have gained popularity as the method of choice for therapy of atherosclerosis occlusions for several reasons. The transluminal approach is a less invasive technique that subjects the patient to fewer traumas and a shorter recovery time, especially when compared to bypass grafts, which utilize homologous tissue, such as saphenous vein grafts. Also, the patient often suffers complications at the donor site of the graft that may be worse than the sternotomy and anastomosis.
Although PTCA procedures are often successful, complications such as restenosis or thrombosis and embolism can occur. Restenosed vessels may often require surgical intervention for correction. The surgical correction of restenosis, like the conventional coronary bypass surgical procedure, oftentimes required the heart to be stopped and the patient placed on a heart/lung bypass machine during the procedure.
In recent years, and in an effort to reduce expense, risk and trauma to the patient, physicians have turned to alternate approaches to heart surgery, including less invasive procedures such as intercostal and endoscopic access to the surgical site. Additionally, beating heart surgery has begun to replace cardiopulmonary bypass surgery using a pump. With such procedures, the heart is beating during the surgical procedure. Thus, there is no need for any form of cardiopulmonary bypass and there is no need to perform the extensive surgical procedures necessary to connect the patient to such a bypass machine.
Over the years, there have been many attempts at performing minimally or less invasive bypass grafting on a beating heart. Until recently, these techniques have been thought of as being dangerous and difficult because of the delicate nature of the surgical procedure, the lack of adequate access through a reduced surgical field, and the lack of a way to adequately stabilize and reduce tissue movement at the graft site. These procedures are performed while the heart muscle is continuing to beat so that the heart continues to move in a three dimensional movement and the blood continues to flow while the surgeon attempts to evaluate the vessel and then sew the graft in place. Also, the surgical procedure to install the graft requires placing a series of sutures through the wall of an extremely small vessel and onto the artery and heart tissue while the heart continuously moves during the procedure. It is necessary that these sutures be fully and securely placed so the graft is firmly in position and does not leak.
There is disclosed in U.S. Pat. No. 5,730,757, an access platform for the dissection of an internal mammary artery. The described access platform has first and second blades interconnected to a spreader member that laterally drives the blades apart together and support pads interconnected to the first blade. A torsional member is operably interconnected to the first blade and the spreader member and is used to vertically displace the first blade in either direction. Thus, increasing the surgeon""s working space and visual access for the dissection of the internal mammary artery. A tissue retractor interconnected to the blades is used to draw the soft tissue around the incision away from the surgeon""s work area. It is further provided that the access platform can include a port that can be used to mount a heart stabilizer instrument.
There also is described in U.S. Pat. No. 5,875,782 granted to Ferrari et al. and U.S. Pat. No. 5,894,843 granted to Benetti et al. an apparatus for stabilizing the predetermined area on a heart or other organ of a patient to enable a surgical procedure on a beating heart. The apparatus includes a bifurcated member having two elongated prongs and an elongated handle. The handle segment can be movably attached to a rib retractor so that a person is not required to hold the handle segment. In one disclosed embodiment, the apparatus further includes a device to hold the bifurcated member in a desired position against the surface of the heart so that a stabilizing force is applied against the heart.
There also is described in U.S. Pat. No. 5,836,311 granted to Borst et al. an apparatus for stabilizing the predetermined area on a heart or other organ of a patient to enable a surgical procedure on a beating heart. The apparatus includes a single legged or bifurcated member having a plurality of suction members thereon which are attached to the surface of the heart using suction pressure. The arm portion of this device can be movably attached to a rib retractor or other surgical device so a person is not required to hold the handle segment and the suction device may be locked into position against the surface of the heart.
It is therefore desirable to provide a new system and devices related thereto for stabilizing a predetermined area of the body, such as the heart and methods related thereto. It is particularly desirable to provide such a system and devices thereto that are less complex and more user friendly in comparison to prior art devices. Such systems and devices thereto preferably are simple in construction, versatile and are preferably low profile to minimize obstruction of the view of the surgeon or nurse to the surgical field.
The present invention features a system for retracting, stabilizing or manipulating a predetermined area of a body. The system includes a surgical retractor, a stabilization arm or apparatus and a tissue support or stabilization device, and methods of use related thereto. Also featured is a system that also supports any of a number of surgical implements, for example a diaphragm retractor, a valve retractor, a light or a suction device for use during a surgical procedure. The stabilization system and related devices and apparatuses thereto that are featured herein are particularly advantageous for use in performing off-pump coronary artery bypass grafting procedures in which the heart remains beating during the surgical procedure. One advantage of the present invention relates to the use of the stabilization arm to provide a low profile stabilization system so that obstruction of the physician""s view of the surgical site is minimized. Another advantage of the present invention relates to the use of the sled member on the arms of the retractor and even more preferably on the rack segment of the retractor. Additionally, the sled member of the present invention allows for a full range of motion that is controlled by a single knob that is easily manipulated by the surgeon.
The stabilization device preferably includes a device of the type commonly known as the Cohn Cardiac Stabilizer marketed by the Genzyme Corporation of Cambridge Mass., although horseshoe or suction type devices may also be used. The preferred form of the stabilization device is a generally square or rectangularly shaped member having a planar surface with centrally located opening therein. This opening is the area through which the surgeon performs the anastomosis or other procedure on the tissue of the beating heart. The stabilization device is preferably a two piece member so that once the anastomosis is completed, the pieces may be separated to remove the device from around the anastomosis. As described more fully below, flexible tapes are sutured through the tissue and then threaded through the stabilizing device. Once the stabilization device is positioned in the desired orientation and location, the flexible tapes are then pulled snug through the opening of the stabilization device to provide a system which captures the tissue and minimizes the overall movement of the predetermined area of the tissue.
The stabilization arm of the present invention preferably includes an elongated handle having a first or distal end portion and a connector thereon for releasably connecting the stabilization device to the elongated handle first end. This connection allows the stabilization device to be pivotally and slidably moved to a desired position into contact with the predetermined area of the tissue of the patient while minimizing the interference of the stabilization device and stabilization arm with the field of view in the surgical field. The stabilization arm also includes a mounting mechanism or sled member through which the stabilization arm is preferably slidable. The stabilization arm may also be positioned on either side of the vertical pivot point of the sled member to further increase the versatility of the stabilization system to allow the stabilization device to be positioned in the desired location of the surgical site. Alternately, one form of the sled member may also be oriented at an angle relative to the retractor to further increase the versatility of the present invention. Additionally, the stabilization arm may be straight or curved to provide the surgeon with yet another choice to obtain the best access to the desired surgical site.
According to one aspect of the present invention, the arms and rack surface of the retractor are configured with a plurality of mounting surfaces thereon. The mounting surfaces are preferably equally spaced along substantially the entire length thereof. The mounting surface is preferably spaced apart a predetermined and consistent distance from the front edge and is also preferably located on the interconnecting or rack segment of the retractor. Also, the stabilization arm preferably includes a sled member that is configured to removably engage the mounting surface at a desired location on one or more of the arms or the rack segment of the retractor. The sled member includes a lever or knob member for selectively engaging a mounting surface on the arm or rack segment of the retractor so the sled member is removably and adjustably secured to the arms or the rack segment of the retractor.
Each of the features described herein enable the user to determine the optimum position for the stabilization arm and stabilization device while ensuring that the surgeon""s view of the surgical site is not unnecessarily obstructed. Additionally, these features allow the present invention to be used in many different medical procedures because of the versatility of system set up and orientation of the components of this invention.
Other aspects and embodiments of the invention are more fully discussed below.